A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of Pioglitazone (PGZ) on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC) and the Effect of CVC on the PK of PGZ
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC
研究概览
简要总结
A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK of PGZ administered with and without CVC.
详细描述
This is a open-label, fixed-sequence, 3-period study being conducted in a single center to evaluate the following:
- PK of CVC administered with and without PGZ
- PK of PGZ administered with and without CVC
- Safety of CVC administered with and without PGZ
- Tolerability of CVC administered with and without PGZ
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •BMI ≥ 18 and ≤ 35 kg/m2
- •No clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations, and 12-lead ECG
- •Agree to comply with the study procedures and restrictions
排除标准
- •Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant conditions as determined by the investigator
- •History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy
- •Serum ALT, AST or bilirubin ≥ grade 1 (ALT and AST > ULN - 3.0 x ULN; bilirubin > ULN - 1.5 x ULN) at screening
- •Positive for HIV, HBV or HCV infection
- •Use of any prescription drugs or prohibited medications within 30 days from the first dose of the study medication
- •Use of alcohol-containing or caffeine-containing foods or beverages within 72 hours prior to the first dose of study medication
研究组 & 干预措施
Group 1 (Cenicriviroc, PGZ, CVC+PGZ)
Treatment A: CVC 150 mg QD for 10 days followed by 10-day washout Treatment B: PGZ 45 mg QD for 10 days Treatment C: co-administration of PGZ 45 mg QD + CVC 150 mg QD for 10 days
干预措施: Cenicriviroc (Drug)
Group 2 (Pioglitazone, CVC, CVC+PGZ)
Treatment B: PGZ 45 mg QD for 10 days followed by 10-day washout Treatment A: CVC 150 mg QD for 10 days Treatment C: co-administration of CVC 150 mg QD + PGZ 45 mg QD for 10 days
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC
时间窗: Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40
PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.
Pharmacokinetic Assessment of PGZ, as measured by Cmax, Cmin and AUC
时间窗: Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40
PK profile will be calculated based on PGZ exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.
次要结局
- Changes from Baseline in Vital Signs(40 days)
- Evaluation of Adverse Events(40 days)
- Changes from Baseline in 12-lead ECGs(40 days)
- Changes from Baseline in Physical Examinations(40 days)
- Changes from Baseline in Clinical Laboratory Tests(40 days)